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A Study of ALM-488 to Highlight Nerves in Patients Undergoing Head & Neck Surgery

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04420689
Recruitment Status : Recruiting
First Posted : June 9, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Alume Biosciences, Inc.

Brief Summary:
Phase 1/2 study of ALM-488 to highlight nerves in patients undergoing head & neck surgery.

Condition or disease Intervention/treatment Phase
Parotid Neoplasm Thyroid Neoplasms Head and Neck Neoplasms Surgery Nerve Injury Imaging Drug: ALM-488 Phase 1 Phase 2

Detailed Description:
This study will evaluate the safety, tolerability, and efficacy of ALM-488 administered as an intravenous (IV) infusion to patients undergoing head & neck surgery. The study will also characterize the pharmacokinetics of ALM-488 in this subject population and determine the dose of ALM-488 needed to generate a fluorescence signal in nerve tissue to enable fluorescence recordings and image analysis with an imaging system. The study will also evaluate the effect of timing of ALM-488 administration, relative to surgery, on fluorescence characteristics.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: This is a Phase 1/Phase 2 study in patients undergoing Head & Neck Surgery.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Phase 1/2 Trial of ALM-488 in Patients Undergoing Head & Neck Surgery
Actual Study Start Date : June 18, 2020
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : June 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dose Escalation/De-Escalation Cohorts
This arm of the study will include Dose Escalation/De-Escalation cohorts of ALM-488.
Drug: ALM-488
ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.

Experimental: Dose Timing Cohorts
This arm of the study will include Dose Timing cohorts of ALM-488.
Drug: ALM-488
ALM-488 Sterile Solution is an intravenously administered, synthetic, peptide dye conjugate indicated for the real-time intraoperative fluorescence detection and localization of nerve tissue.




Primary Outcome Measures :
  1. Incidence of ALM-488 related Adverse Events [ Time Frame: 28 (+5) days ]
    Incidence of ALM-488 related Adverse Events according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v5.0.


Secondary Outcome Measures :
  1. Concentration of ALM-488 in blood [ Time Frame: 28 (+5) days ]
    Concentration of ALM-488 in blood at varying times following ALM-488 administration.

  2. Dose determination [ Time Frame: 9 months ]
    To determine the recommended dose of ALM-488.

  3. Timing determination [ Time Frame: 3 months ]
    To evaluate the effect of timing of administration of ALM-488.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. A neoplasm located in the head and neck.
  2. Primary surgical treatment is by parotidectomy, or thyroidectomy, or cervical neck dissection.
  3. Can understand and is willing to sign a written informed consent document.
  4. ≥18 years of age.
  5. Life expectancy of at least 6 months.
  6. Normal liver and kidney functions.
  7. If of childbearing potential, must have a negative urine or serum pregnancy test and be using a medically acceptable form of contraception (e.g., hormonal birth control, intrauterine devices, double-barrier method) or abstinence. The subject, if male, must use a medically acceptable form of contraception (e.g. condom) or abstinence.
  8. Plans to undergo head and neck surgery.

Exclusion Criteria:

  1. Prior radiation or chemotherapy for any prior head and neck neoplasm.
  2. Open surgery in the ipsilateral head and neck within 1 year.
  3. Abnormal cardiac rhythm not controlled with medication, history of stroke, coronary events and/or heart failure within 1 year.
  4. Current evidence of renal disease.
  5. Pregnant or breastfeeding.
  6. Unresolved acute toxicity from prior anti-cancer therapy.
  7. History of fluorescein allergy.
  8. Any other criteria deemed by the Principal Investigator that may prevent the patient from successfully completing the trial.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04420689


Contacts
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Contact: Dan Harvey, PhD 858-366-5058 clinical.trial@alumebiosciences.com

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92037
Contact: Principal Investigator         
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Principal Investigator         
United States, Massachusetts
Harvard-Mass Eye & Ear Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Principal Investigator         
Sponsors and Collaborators
Alume Biosciences, Inc.
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Responsible Party: Alume Biosciences, Inc.
ClinicalTrials.gov Identifier: NCT04420689    
Other Study ID Numbers: ALM-488-001
First Posted: June 9, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Alume Biosciences, Inc.:
Nerve
Fluorescence
Surgery
Imaging
Real-time
Intraoperative
Highlighting
Additional relevant MeSH terms:
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Neoplasms
Head and Neck Neoplasms
Thyroid Neoplasms
Parotid Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Endocrine System Diseases
Thyroid Diseases
Salivary Gland Neoplasms
Mouth Neoplasms
Mouth Diseases
Stomatognathic Diseases
Parotid Diseases
Salivary Gland Diseases